Senior Clinical Trial Associate

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

GENERAL JOB FUNCTIONS:

The Clinical Trial Associate (CTA) supports the operational execution of clinical trials from start-up through close-out. This role partners closely with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials are conducted efficiently, compliantly, and in alignment with program and company objectives.

Key Responsibilities

• Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
• Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
• Collect, track, and review investigator site regulatory documentation (e.g., FDA Form 1572, FDFs, CVs, medical licenses, and study-specific documents) for completeness and accuracy.
• Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH-GCP and company SOPs.
• Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
• Ensure clinical trial management systems (company and/or CRO systems) are kept current in collaboration with the Clinical Trial Leader (CTL).
• Support study start-up, conduct, monitoring, and close-out activities to ensure protocol adherence and regulatory compliance.
• Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
• Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
• Provide operational and financial support, including purchase orders, contract setup, invoice processing, and tracking of study budgets.
• Assist with development, review, and maintenance of study documents (e.g., protocols, ICFs, CRFs, monitoring plans, manuals).

Sr. CTA:

• Highly experienced with using different eTMF systems (e.g., Veeva Vault, etc.)
• Accountable for projects within a clearly defined scope and milestones.
• Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance or direction within clear or even broad guidelines.
• Drive harmonization of processes throughout Clinical Operations, use best practices to improve products or services
• Contribute to mentoring, training and provision of direction and guidance to increase knowledge of new team members / new employees
• Make process improvement suggestions and develop new process approaches
• Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
• Take on additional tasks as assigned by management
• Proficient in using and training other CTAs & CTLs on the financial tools / systems to create accurate financial documents
• Independently execute tasks outlined in the General portion of Essential Job Requirements.
• Close collaboration with CTA Line Manager to align on new concepts, address resource topics, exchange status updates
• Responsible for driving and guiding the respective group, while implementing efficient processes, data driven approaches, tools, and training
• Responsible to conduct and lead CTA trainings and meetings on request
• Responsible to monitor quality and compliance of CTA implemented processes
• Role Model and represent / present the CTA Team to Leadership as well as internal / external functions, if needed

JOB SPECIFICATIONS: